GLP 0: Good Laboratory Practice, Overview

Duration: 1 Hour and 45 Minutes

Certificate of Completion:

Provided immediately upon successful completion.

GLP 0: Good Laboratory Practice, Overview Description: This course will introduce you to the concepts and requirements necessary for compliance with Good Laboratory Practice (GLP). This course will help prepare you to establish and document a system of GLP controls required to test medical products where data is intended for inclusion into a regulatory filing in the United States, the European Union, Japan, and in many parts of the world.

Accreditation: GeneEd designates this educational activity for a maximum of 1.75 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.

GeneEd, Inc. is accredited by the Institute for Medical Quality/California Medical Association (IMQ/CMA) to provide continuing medical education for physicians. GeneEd, Inc. takes responsibility for the content, quality and scientific integrity of this CME activity.

In addition to physicians, GeneEd Online Training Courses are also applicable for nurses (RNs), doctors (MD and PhDs), clinical research associates (CRAs or monitors), clinical research coordinators (CRCs), investigators, researchers, bioprocess / biomanufacturing workers, QA/QC managers, other healthcare professionals and for patient education.

GLP 0: Good Laboratory Practice, Overview

OUTLINEINTRODUCTION

1. Course Information

2. Interface Tour

3. Course Overview

PURPOSE AND ELEMENTS OF GLP

4. Objectives

5. Pre-Test

6. Origins of the GLP Regulations

7. Protocols and Reports

8. Quality Assurance Program

9. Inspections of GLP Labs

10. Progress Check

GLP RESPONSIBILITIES

11. Objectives

12. Pre-Test

13. Responsibilities of Management and Personnel

14. Responsibilities of the Study Director

15. Responsibilities of Quality Assurance

16. Progress Check

AREAS OF GLP

17. Objectives

18. Pre-Test

19. Facilities and Instrumentation

20. Reagents and Solutions

21. Animal Care

22. Test and Control Materials

23. Progress Check

DOCUMENTATION

24. Objectives

25. Pre-Test

26. Standard Operating Procedures

27. Document Change Control

28. Data Recording Rules

29. Records/Archive Management

30. Progress Check

CONCLUSION

31. Summary

OBJECTIVES: Students completing this course, GLP 0: Good Laboratory Practice, Overview, should be able to:

List the purpose of Good Laboratory Practice (GLP) regulations.

Describe two events that inform the institution of the GLP regulations.

Describe four elements of GLP.

Discuss the three areas that will be reviewed during a GLP inspection.

List the responsibilities of Management.

Understand Personnel responsibilities.

Describe the responsibilities of the Study Director.

Discuss the responsibilities of Quality Assurance.

Understand the GLP area of Facilities and Instrumentation.

Describe Standard Operating Procedures.

Discuss the GLP area of Reagents and Solutions.

Understand the GLP area of Animal Care.

Describe the GLP area of Test and Control Materials.

Describe the purpose of SOPs and document change control.

List the records required under GLP.

List the data recording rules intended to demonstrate the integrity of nonclinical study data.

Describe the retention period for GLP study data.

About GeneEd's Online Training:

* GeneEd Online Training Courses are high-quality, Flash driven, learning tools including voiceovers and dynamically engaging graphic animations.

* This GeneEd Online Training Course is accessible for 90 days via the Internet, and a Certificate of Completion is accessible once requirements are filled.

* GeneEd Online Training Courses have an instructional design which encourages knowledge retention and long term recollection.

* GeneEd Online Training Courses are developed for healthcare professionals (nurses and doctors), clinical researchers, and for patient education.

* To access your GeneEd Online Training Course, your username, password and login URL will be provided to you shortly after ordering.

Unit 3 of 6
Price: $175.00 / GBP115.50